Data entry is one of the most time consuming and resource intensive processes in clinical research. Without automation, this process requires significant avoidable manual work for data entry and quality monitoring. It is difficult to scale, limits the data collection design, raises quality control difficulties, and is often an expensive study component. Data quality issues slow down studies and can cause delays in regulatory approvals.
Our solution is CLEHR
CLEHR automates the EHR-EDC data transfer and helps to improve productivity by eliminating data errors and source data verification, allowing trained personnel to be freed for advanced research purposes. It provides a controlled process to confirm patient identities that match research protocol criteria to obtain data. CLEHR enhances visibility to improve quality by extracting EHR data on a more timely basis.
Become a more attractive sponsor to work with
Health systems want to collaborate with sponsors having well-established research standards. CLEHR facilitates good quality research by eliminating technical issues and delivering data aligned with regulatory approvals. It facilities working with health systems on multiple studies to accelerate bringing innovations to market. CLEHR was designed with the health system’s priorities in mind by leveraging prior investments and security standards to achieve improvements across studies.
Health IT systems using FHIR are designed to exchange records with PHI. This presents a challenge to sponsor owned technology by exposing sponsors to the risk and complexity that goes into storing identified patient records.
As a CRO, Graticule provides honest broker services by establishing BAAs with the health system and delivering de-identified data. By working on multiple studies with standard tools and legal agreements Graticule accelerates the implementation and operationalization of each study
CLEHR benefits for sponsors
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| Improvement in Productivity | Reduce risk | Supports many studies |
| Reduce manual labor for duplicate data entry and manual quality checks Total study time can be reduced by weeks or months with the help of automation | Third party honest broker responsible for de-identification Secure and compliant environment that is trusted by Health Systems Reduce contracting risk through proven business agreements and technical reviews | One-time set-up infrastructure can be utilized for multiple studies Graticule research network provides new sites with automation-ready integration |